Z-1887-2019Class II

EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 -

Name: Z-1887-2019 EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 -
Creator: AtriCure, Inc.
Published: 2019-05-29
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2019-05-29 / Terminated / root cause: manufacturing process

FDA source

AtriCure, Inc. began a recall of EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a... on 2019-05-29. FDA classified it as Class II and gives the reason as "The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1887-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-06-26
Terminated: 2020-05-04
Recalling firm: AtriCure, Inc.
Product: EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 29, 2019, the firm notified customers of the recall via Urgent Advisory Notice. Customers were asked to take the following actions: " Immediately quarantine any affected product as identified within this Advisory Notice. " Contact AtriCure product complaints by phone at 1-866-349-2342 (select option 6) or e-mail to [email protected] to request a Return Goods Authorization (RGA). " Return the attached Acknowledgement Form. See Attachment B. The acknowledgement form must be completed and returned even if product is not on hand by selecting the second option. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly. This advisory issue will also be posted on AtriCures website at www.atricure.com/products.
Quantity in commerce: 497
Distribution: Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.
Product codes and lots: Lots 70638, 71332, 89208, 89938, 90624

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1887-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1887-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26

Product code OCL

K142084Class IIEpi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc. / cleared 2014-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)